No Benefit with Paclitaxel Consolidation in Advanced Ovarian Cancer
Reported September 01, 2009
NEW YORK (Reuters Health) – A paclitaxel consolidation regimen does not improve either disease-free or overall survival in women with advanced epithelial ovarian cancer who had complete responses to first-line paclitaxel/platinum-based regimens, according to a report in the August 24th Journal of Clinical Oncology.
“For patients who achieve a complete response (negative clinical examination, negative ultrasound or CT scan, normalized serum CA 125 levels), prolonged chemotherapy is not useful and gives only additional toxicity,” Dr. PierFranco Conte from University of Modena and Reggio Emilia, Modena, Italy, told Reuters Health by email.
In a randomized trial involving 200 women who were in complete remission after first-line paclitaxel/platinum-based chemotherapy, Dr. Conte and his colleagues compared the effects of 6 courses of paclitaxel maintenance, given as 175 mg/m2 every 3 weeks, and observation.
After a median follow-up of 43.5 months from the date of assignment, 2-year progression-free survival rates did not differ significantly between the consolidation (59%) and control (54%) arms of the study, the authors report.
Two-year overall survival rates were also similar for the 2 treatment groups (87% for consolidation, 90% for controls).
Residual disease after initial surgery and FIGO stage were independent prognostic factors for progression-free survival, the researchers note, whereas treatment arm had no prognostic relevance.
“Until some definitive answers about maintenance chemotherapy are achieved,” the investigators conclude, “such treatment remains experimental and should only be evaluated in patients at high risk of recurrence.”
“Some clinico-pathological features (i.e., initial stage of disease, amount of residual disease after primary surgery) can be helpful to identify those patients who, in spite of achieving a complete response, are at higher risk of early relapse,” Dr. Conte said. “New experimental therapies should be focused on these patients.”
Source:J Clin Oncol 2009.
